Mechanical Engineer - Medical Device Hardware & QA

Custom Health; Morrisville (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

Spencer Health Solutions in Morrisville, NC seeks a Mechanical Engineer to join the hardware team working on Spencer’s medical device platforms. You will design, model, and qualify components while collaborating across engineering for compliant, high-quality results.

Your role supports change management, project planning, and continuous process improvement within a regulated environment. A degree in mechanical engineering with 4–10 years’ relevant experience is required.

Qualifications

• Degree in mechanical engineering.
• 4 to 10 years’ experience designing and developing commercial or consumer products.
• Experience drafting and modeling in parametric CAD; SolidWorks preferred.
• Experience in prototyping & prototyping with plastics (injection molding).
• Strong knowledge of hardware qualification testing of POC’s.
• Ability to read, understand, and execute SOPs in a regulated environment.
• Strong interpersonal and problem-solving skills.

Responsibilities

• Drafting and modeling of hardware components.
• Collaborate with engineers to define new products and ensure requirements are met.
• Perform hardware qualification testing of POC designs.
• Analyze designs, run tests, and identify opportunities for design or cost improvements.
• Qualify vendors per Spencer’s specifications.
• Participate in process improvement activities.
• Create manufacturing instructions and specifications.
• Ensure all hardware design activities comply with Spencer’s Quality Management System.

Skills

Mechanical design

Problem solving

Interpersonal skills

Regulatory awareness

Education

Bachelor's degree in Mechanical Engineering

Tools

SolidWorks

CAD

Prototyping

Injection Molding

Quality testing (POCs)

Job description

Spencer Health Solutions in Morrisville, NC seeks a Mechanical Engineer to join the hardware team working on Spencer’s medical device platforms. You will design, model, and qualify components while collaborating across engineering for compliant, high-quality results.

Your role supports change management, project planning, and continuous process improvement within a regulated environment. A degree in mechanical engineering with 4–10 years’ relevant experience is required.